Advanced Medical Solutions Grp PLC FDA approval for two woundcare portfolio dressings (4012X)
August 10 2018 - 2:00AM
UK Regulatory
TIDMAMS
RNS Number : 4012X
Advanced Medical Solutions Grp PLC
10 August 2018
10 August 2018
Advanced Medical Solutions Group plc
("AMS", the "Company" or the "Group")
FDA approval for two woundcare portfolio dressings
US launches expected in Q4 18
Winsford, UK, 9 August 2018: Advanced Medical Solutions Group
plc (AIM: AMS), the surgical and advanced wound care specialist
company, today announces that it has received notice from the FDA
("Food and Drug Administration") in the US, of Premarket 510(k)
approvals for the Group's Surgical Silver Post Operative Dressing
and for PHMB Foam Dressing.
These new approvals will allow AMS and its distribution partners
to offer clinicians advanced woundcare dressings that help prevent
and treat infection and accelerate the healing of chronic and high
risk surgical wounds, saving time and cost burden to the payors. It
is expected that both of these products will be launched in the US
in the fourth quarter of 2018.
The Surgical Silver Post Operative Dressing is indicated for use
in the management of post-operative surgical wounds and consists of
two skin-friendly layers of hydrocolloid securing a
silver-containing absorbent antibacterial alginate dressing. It has
been shown to be effective against Methicillin-Resistant S. aureus
(MRSA) as well as a broad spectrum of microbes including other
antibiotic resistant strains.
The PHMB Foam Dressing is a polyurethane foam impregnated with
Polyhexamethylene Biguanide (PHMB) that is indicated for use in the
management of various chronic and post-surgical wounds including
pressure sores, diabetic ulcers, and burns. The PHMB Foam dressing
has also been shown to be effective against MRSA and a broad
spectrum of microbes.
Chris Meredith, Chief Executive Officer of Advanced Medical
Solutions, said: "These most recent approvals strengthen our
advanced woundcare portfolio in the US and provide further
significant products to support our OEM customers and end users. We
are particularly pleased to be able to demonstrate the value of our
R&D and Regulatory capabilities which are a key pillar of our
strategy to drive organic growth."
- End -
For further information, please visit www.admedsol.com or
contact:
Advanced Medical Solutions Group plc Tel: +44 (0) 1606
545508
Chris Meredith, Chief Executive Officer
Mary Tavener, Chief Financial Officer
Consilium Strategic Communications Tel: +44 (0) 20 3709
5700
Mary-Jane Elliott / Matthew Neal / Nicholas AMS@consilium-comms.com
Brown / Olivia Manser
Investec Bank PLC (NOMAD & Broker) Tel: +44 (0) 20 7597
5970
Daniel Adams / Gary Clarence / Patrick
Robb
About Advanced Medical Solutions Group plc - see
www.admedsol.com
AMS is a world-leading independent developer and manufacturer of
innovative and technologically advanced products for the global
surgical, wound care and wound closure markets, focused on quality
outcomes for patients and value for payors. AMS has a wide range of
products that include silver alginates, alginates, foams, tissue
adhesives, sutures and haemostats, which it markets under its
brands; ActivHeal(R) , LiquiBand(R) and RESORBA(R) as well as
supplying under white label.
AMS's products, manufactured out of two sites in the UK, one in
the Netherlands, two in Germany and one in the Czech Republic, are
sold in more than 75 countries via a network of multinational or
regional partners and distributors, as well as via AMS's own direct
sales forces in the UK, Germany, the Czech Republic and Russia.
Established in 1991, the Group has approximately 600 employees. For
more information, please see www.admedsol.com.
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END
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